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1 in 3 New Drugs Approved by the FDA Had Some Unexpected Complications

May 10, 2017 09:09 AM EDT
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There are over 100 post-market safety events in more than 200 prescription drugs approved by the FDA from 2001 through 2010
(Photo : Matt Cardy/Getty Images)

A new study revealed that nearly one-third of the new drugs approved by the Food and Drugs Administration experience major safety issues just years after being made commercially available for public consumption.

The new analysis, published in the Journal of American Medical Association, showed that there are over 100 post-market safety events in more than 200 prescription drugs approved by the FDA from 2001 through 2010. Out of those drugs, 71 required an action from the FDA.

"While the administration pushes for less regulation and faster approvals, those decisions have consequences," said Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine and senior author of the study, in a report from National Public Radio. "In the 21st Century Cures Act, there's a push to have the FDA move to further support the use of surrogate markers ... [but] they're more likely to have concerns in the post-market setting."

For the study, the researchers analyzed all novel therapeutics, both pharmaceuticals, and biologics, approved by the FDA between January 1, 2001, and December 31, 2010. The FDA approved a total of 222 new drugs during the study period, which includes 183 pharmaceuticals and 39 biologics.

During a median follow-up period of 11.7 years, the researchers found 123 new post-market safety events affecting 71 of the FDA-approved drug. These safety events include three withdrawals, 61 boxed warning and 59 safety communications.

Out of the drugs affected by the safety concerns, medications used to treat mental illness that underwent accelerated approval process were more likely to experience safety events. Some of the safety issues discovered after the drugs' approval include serious skin reactions, liver damage, cancer and even death.

The researchers noted that the high number of post-market safety events regarding newly approved drugs should be taken positively. The result of their analysis suggests that the FDA is "kind of doing a great job" in monitoring approved drugs after being released in the market.

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